Urgent Medical Device Recall letters and emails were distributed on March 29, 2018.
Distributors Responsibilities:
1. Review this notification and ensure that affected team members are aware of the contents.
2. Immediately locate and quarantine affected product in your inventory.
3. Immediately return all affected product from your distributorship and from affected hospitals within your territory.
a. Complete Attachment 1 Inventory Return Certification Form and send to CorporateQuality.PostMarket@zimmerbiomet.com within three (3) days.
b. International distributors can request a International Return Authorization by emailing zimmerbiometintlirarequests@zimmerbiomet.com for returns
c. For each return, send a copy of Attachment 1 to CorporateQuality.PostMarket@zimmerbiomet.com.
d. Include a hardcopy of Attachment 1 in each carton of your return shipment for immediate processing.
e. Mark RECALL on the outside of the returned cartons.
4. Return the Additional Accounts form to CorporateQuality.PostMarket@zimmerbiomet.com.
a. Review the list of hospitals and/or surgeons included with the email notification sent to your facility, which includes a list of hospitals and/or surgeons that have already been notified of this recall.
b. Identify whether there are any additional hospitals and/or surgeons that Zimmer Biomet has not notified and list these accounts on the Additional Accounts form. Please provide the form in Excel format.
c. If there are no additional accounts or surgeons to notify, please indicate that there are no additional accounts, or indicate None or NA on the form.
5. Retain a copy of your Inventory Return Certification and product return forms for your records in the event of a compliance audit of your facility.
6. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating ho

Quantity in Commerce

1,145 distribution events. Note that this product is lot controlled and may be distributed multiple times if it was returned and returned to the shelf

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.